- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040620
Effectiveness of Olive Oil Local Application in Orthodontic Patients.
Effectiveness of Olive Oil Local Application in Decreasing the Period of Alignment Phase in Non Extraction Orthodontic Patients. A Randomized Controlled Clinical Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During the orthodontic treatment, the friction between the bracket and the arch-wire could prevent the action of forces required for a particular tooth movement. Studies demonstrated that approximately 12 to 60% of the force used to move a tooth is dissipated in the form of friction. Consequently, a delay could occur in the biological response to orthodontic movement. The most important factors that may have an impact on friction are; the composition of the bracket, the arch-wire alloy, the cross-sectional size of the arch-wire, the type of ligation system and the surface roughness of the bracket-archwire assembly.
In addition to the factors related to the orthodontic appliances, saliva is considered to be a biological variable associated with friction, as it acts as a lubricant during sliding mechanics.This fact should be taken into account in laboratory studies that aim to evaluate the performance of the archwire-bracket combinations. However, in the majority of the research studies, the friction test has been conducted without the use of any lubricant, which does not represent the clinical reality where there is saliva introduced during the movement of the arch-wire on the bracket. To remedy this situation, distilled water has been used as a lubricant. Although in this case the test is conducted in the presence of a lubricant, water does not have the lubricating ability of natural human saliva.
It is well known that oil is a well-known lubricant. But how we can use it to decrease friction between brackets and wires? and which type of oil we can use safely in patient mouth? Olive oil (OO) (Olea europaea, Oleaceae) is a fundamental component of the Mediterranean Diet; it is a mix of fatty acids such as oleic and linoleic acid, secoiridoids (oleuropein and oleocanthal), simple phenols (tyrosol and hydroxytyrosol), lignans (pinoresinol), flavonoids (apigenin), hydrocarbons (squalene), triterpenes (maslinic acid), and phytosterols (β-sitosterol).
The large body of evidence supports the chemotherapeutic potential of substances found in OO, acting on different sides, such as inflammation, oxidative damage, and even epigenetic modulation. The consumption of OO should be suggested in a healthy diet instead of other types of oils. It looks worthy, to determine the effect of local application of Olive Oil in decreasing the friction between brackets and wires during orthodontic treatment.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Ahmed Nasef, lecturer
- Phone Number: 002-01003383457
- Email: a.nasef_ortho@hotmail.com
Study Contact Backup
- Name: Asmaa Mahmoud, lecturer
- Phone Number: 002-01002966412
- Email: dentistasmaa_biology@hotmail.com
Study Locations
-
-
-
Minya, Egypt, 61111
- Recruiting
- Ahmed Nasef
-
Contact:
- Ahmed Nasef, lecturer
- Phone Number: 002-01003383457
- Email: a.nasef_ortho@hotmail.com
-
Contact:
- Asmaa Mahmoud, lecturer
- Phone Number: 002-01002966412
- Email: dentistasmaa_biology@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The age of patients ranges from 15-20 years old.
- Mild to moderate dental irregularity requiring non-extraction treatment.
- Presence of all the permanent teeth at least up to the first molars.
- Good oral hygiene, and periodontal health.
Exclusion Criteria:
- Patients require orthognathic surgery to correct skeletal discrepancies.
- patients who are taking medications, like NSAIDs or other anti-inflammatory drugs.
- cleft lip or palate patients.
- patients with hypodontia, or hyperdontia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Placebo
controlling group who will receive traditional orthodontic treatment.
|
|
Experimental: Olive Oil
experimental group who will receive the local application of Olive Oil five times daily after teeth brushing
|
the effect of olive oil local application in decreasing orthodontic alighment phase
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The duration of orthodontic teeth aligning using Little irregualrity index
Time Frame: 4 months
|
To detect the effect of local usage of Olive Oil on orthodontic brackets during the alignment phase of orthodontic treatment in changing the Little's irregularity in- dex.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
orthodontic wire surface roughness changes
Time Frame: one month
|
To examine the change in surface roughness of Nickel-Titanium and stainless steel archwires when using Olive Oil as a lubricant and without usage of a lubricant.
|
one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Nasef, lecturer, lecturer of orthodontics, Minia University
Publications and helpful links
General Publications
- Ehsani S, Mandich MA, El-Bialy TH, Flores-Mir C. Frictional resistance in self-ligating orthodontic brackets and conventionally ligated brackets. A systematic review. Angle Orthod. 2009 May;79(3):592-601. doi: 10.2319/060208-288.1.
- Chimenti C, Franchi L, Di Giuseppe MG, Lucci M. Friction of orthodontic elastomeric ligatures with different dimensions. Angle Orthod. 2005 May;75(3):421-5. doi: 10.1043/0003-3219(2005)75[421:FOOELW]2.0.CO;2.
- Carrion-Vilches FJ, Bermudez MD, Fructuoso P. Static and kinetic friction force and surface roughness of different archwire-bracket sliding contacts. Dent Mater J. 2015;34(5):648-53. doi: 10.4012/dmj.2014-295.
- Matarese G, Nucera R, Militi A, Mazza M, Portelli M, Festa F, Cordasco G. Evaluation of frictional forces during dental alignment: an experimental model with 3 nonleveled brackets. Am J Orthod Dentofacial Orthop. 2008 May;133(5):708-15. doi: 10.1016/j.ajodo.2006.06.021.
- Yanase Y, Ioi H, Nishioka M, Takahashi I. Effects of sliding velocity on friction: an in vitro study at extremely low sliding velocity approximating orthodontic tooth movement. Angle Orthod. 2014 May;84(3):451-8. doi: 10.2319/060513-427.1. Epub 2013 Oct 25.
- Gorzynik-Debicka M, Przychodzen P, Cappello F, Kuban-Jankowska A, Marino Gammazza A, Knap N, Wozniak M, Gorska-Ponikowska M. Potential Health Benefits of Olive Oil and Plant Polyphenols. Int J Mol Sci. 2018 Feb 28;19(3):686. doi: 10.3390/ijms19030686.
- Gotsis E, Anagnostis P, Mariolis A, Vlachou A, Katsiki N, Karagiannis A. Health benefits of the Mediterranean Diet: an update of research over the last 5 years. Angiology. 2015 Apr;66(4):304-18. doi: 10.1177/0003319714532169. Epub 2014 Apr 27.
- Curto A, Albaladejo A, Montero J, Alvarado A. Influence of a Lubricating Gel (Orthospeed(R)) on Pain and Oral Health-Related Quality of Life in Orthodontic Patients during Initial Therapy with Conventional and Low-Friction Brackets: A Prospective Randomized Clinical Trial. J Clin Med. 2020 May 14;9(5):1474. doi: 10.3390/jcm9051474.
- Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 455
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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